| CTRI Number |
CTRI/2025/03/083318 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Cow Colostrum improves platelet count |
|
Scientific Title of Study
|
Beneficial Effect of Cow Colostrum on Platelet Count – A Multicenter
Global Clinical Trial. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1319-7181 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati Khartode |
| Designation |
Chief Dietitian and Clinical Researcher |
| Affiliation |
Vishwaraj Hospital |
| Address |
OPD No 6,
Department of Dietetics and Nutrition,
Ground Floor,Vishwaraj Hospital, Near Loni station,
Pune- Solapur Road, Loni kalbhor,
Pune- 412201
Pune MAHARASHTRA 412201 India |
| Phone |
9767133699 |
| Fax |
|
| Email |
opd@vrhpune.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Swati Khartode |
| Designation |
Chief Dietitian and Clinical Researcher |
| Affiliation |
Vishwaraj Hospital |
| Address |
OPD No 6,
Department of Dietetics and Nutrition,
Ground Floor,Vishwaraj Hospital, Near Loni station,
Pune- Solapur Road, Loni kalbhor,
Pune- 412201
Pune MAHARASHTRA 412201 India |
| Phone |
9767133699 |
| Fax |
|
| Email |
opd@vrhpune.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Swati Khartode |
| Designation |
Chief Dietitian and Clinical Researcher |
| Affiliation |
Vishwaraj Hospital |
| Address |
OPD No 6,
Department of Dietetics and Nutrition,
Ground Floor,Vishwaraj Hospital, Near Loni station,
Pune- Solapur Road, Loni kalbhor,
Pune- 412201
Pune MAHARASHTRA 412201 India |
| Phone |
9767133699 |
| Fax |
|
| Email |
opd@vrhpune.com |
|
|
Source of Monetary or Material Support
|
| Vishwaraj Hospital
Near Loni station,
Pune- Solapur Road, Loni kalbhor,
Pune, Maharashtra, India
Pin - 412201
|
|
|
Primary Sponsor
|
| Name |
Vishwaraj Hospital |
| Address |
Vishwaraj Hospital, Near Loni station,
Pune- Solapur Road, Loni kalbhor,
Pune- 412201
|
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| APS Biogroup |
APS BioGroup Main Offices and Manufacturing Facilities:
2235 South Central Ave Phoenix, AZ 85004 US
|
| SG dairy Australia |
South Gippsland Dairy Pty. Ltd.
PO Box 26, Korumburra.
Victoria, 3950 |
|
|
Countries of Recruitment
|
United Arab Emirates Australia India Nigeria United Kingdom United States of America |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swati Khartode |
Vishwaraj Hospital |
OPD No 6,
Department of Dietetics and Nutrition,
Ground Floor,Vishwaraj Hospital, Near Loni station,
Pune- Solapur Road, Loni kalbhor,
Pune,
Maharashtra, India
Pin- 412201
Pune MAHARASHTRA |
9767133699
opd@vrhpune.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAEER’S Vishwaraj Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R70-R79||Abnormal findings on examination of blood, without diagnosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cow Colostrum Food Supplement powder |
Cow Colostrum Food supplement 10 gms (2 teaspoons) with water BD for 3 months |
| Comparator Agent |
NONE
Control group will not receive any cow colostrum supplement or placebo |
Not applicable.
Control group will not receive any cow colostrum supplement or placebo |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
To be eligible for the study, Subjects must meet the following criteria:
1. Male or female subjects of age group
10-18 years and 18-75 years
2. Confirmed clinical diagnosis of low platelet count by using complete blood count test (CBC)
|
|
| ExclusionCriteria |
| Details |
Subjects with any of the following conditions will be excluded from the study:
1. Subjects who is having Lactose Intolerance (Allergic to milk).
2. Those who are ‘Pure Vegan’ (Not taking any animal product including milk and milk products).
3. Acute or Chronic Kidney Disease
4. Pregnant females and Lactating mothers |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check increasing trend of platelet count |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Early recovery from the symptoms if any |
3 months |
|
|
Target Sample Size
|
Total Sample Size="800" Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Rationale: Since the time immemorial, man has sought some alternative methods to enhance and improve the immune system of human body in order to fight against diseases. Historically, Ayurvedic physicians have used bovine colostrum for therapeutical application in Asia, particularly in India for thousands of years. Increased awareness of the diet - health relationship in many countries has stimulated a trend in nutrition science whereby more attention is given to the health effects of individual foods. (Seth, R., & Das, A. (2011). Colostrum is the initial milk secreted by bovine during parturition and the first few days after birth. Colostrum is a gift of nature used to protect the newborn’s immune system and provides passive immunity against pathogens. The presence of bioactive components such as insulin-like growth factor I and II (IGF-I and IGF-II), lactoferrin, lysozyme, lactoperoxidase, and immunoglobulin make the colostrum active against many pathogens. It is also active against Herpes simplex virus type-I (HSV-I), Human Immuno-deficiency virus-I (HIV-I), and human cytomegalovirus. Immunoglobulins are considered an important bioactive component in colostrum, and it contains high levels of immunoglobulin G (Ig G). Immuno-supplementation with bovine milk antibodies has been shown to provide local protection to the gastrointestinal tract against disease. (Tripathi, V., & Vashishtha, B. (2006). The world-wide trend towards the development of health-promoting foods offers interesting opportunities for applications which contain specific antibody ingredients derived from immunized cows. It is anticipated that colostrum based preparations may have remarkable potential to contribute to human health care as part of health promoting diet and as an alternative or a supplement to the medical treatment of specified human diseases. Bovine colostrum virtually contain all compounds of human cellular and humoral immune defense. (Seth, R., & Das, A. (2011).
Thus, it has been observed that there is wide study on effect of bovine colostrum on gastro-intestinal diseases, HIV patients, athletes, also cancer patients but lack in study of effect of cow colostrum immunoglobulins on low platelet count induced by viral fever, cancer treatment. All over the world milk and milk products of cow has been eating since Ancient time, it is easily available worldwide, easily digested with good absorption rate. Also colostrum has no side effect like any medicine as it is a food supplement, so there is a need of Study to check the Effect of Immunoglobulins present in Cow Colostrum in low platelet count subjects to increase the platelet count, enhance the immune system and for early recovery rate. In this study we are using cow colostrum which Lactose intolerance people also can eat it but we will exclude those patients. Also these supplements have been prepared by Freeze Dried method so there is no loss of Immunoglobulins. Major components of cow colostrum: The most important components of cow colostrum can basically be broken down into two major categories: Immune system factors and Growth factors. Immunoglobulins (A, D, E, G and M) - the most abundant of the immune factors found in colostrum. Lactoferrin - an antiviral, anti-bacterial, anti-inflammatory, iron- binding protein with therapeutic effects in many diseases. Proline-Rich Polypeptide (PRP) Growth Factors: Epithelial growth factor (EgF) Insulin-like growth factor-I and II (IGF-1 and IGF-II) Fibroblast growth factor (FgF) Platelet-derived growth factor (PDGF) Transforming growth factors A & B (TgA and B) Growth hormone (GH) |